RecruitingPHASE2INTERVENTIONAL

A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

This research study is investigating new ways to treat Crohn's disease, a condition that causes inflammation in the digestive system. We are looking at adults who have moderately to severely active Crohn's disease. The main goal is to compare how safe and effective a new drug called LY4395089 is when given alongside an existing treatment, mirikizumab, compared to mirikizumab on its own. Researchers hope to find out if combining these two treatments could offer better results for patients. This study is part of a larger research programme and will involve participants for about 62 weeks to carefully observe the effects of the treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

Start

04 May 2026

Estimated completion

01 Mar 2028

Crohn Disease

What is this study about?

Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, weight loss, and feeling very tired. While there are treatments available, researchers are always looking for new and better ways to help people manage their condition and improve their quality of life.

This particular study is focusing on two different treatments. One is mirikizumab, a drug that is already being studied and used for inflammatory bowel diseases. The other is a new drug called LY4395089, which works in a different way in the body. The researchers want to see if giving these two treatments together could be more effective or safer than just using mirikizumab by itself.

By taking part in this study, you would be helping doctors and scientists understand more about Crohn's disease and how these new treatments might work. The aim is to find better options for people living with this condition, potentially leading to new ways to control symptoms and improve health in the future.

Key takeaways

This study is testing a new combination of drugs for Crohn's disease.
It aims to see if combining two drugs is safer and more effective.
Participants will be adults with moderately to severely active Crohn's disease.
The study involves regular clinic visits and lasts about 62 weeks.
You will receive study medication and have regular health check-ups.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old with moderately to severely active Crohn's disease. If you are taking certain medications for other conditions – like those for diabetes – you might still be able to join as long as your dose has been stable for some time before the study starts.

However, there are some reasons why you might not be able to take part. For example, if you have liver disease or another bone condition that affects how your bones work, this study might not be suitable for you. Also, if you've had certain heart-related events in the last six months, such as a heart attack, stroke, or heart failure requiring hospitalisation, you wouldn't be able to join.

It's important that you haven't received or are planning to receive any other medications that the study rules say are not allowed. The research team will go through all these details with you carefully to make sure the study is safe and appropriate for your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged between 18 and 80 years old?
Do you have moderately to severely active Crohn's disease?
Have you been diagnosed with liver disease or certain bone diseases?
Have you had a heart attack, stroke, or heart failure requiring hospitalisation in the last 6 months?
Are you able to commit to around 14 months of regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for approximately 62 weeks, which is about 14 months. During this time, you will have regular visits to the clinic where you will receive the study medication. Mirikizumab will be given either directly into a vein (intravenously) or as an injection under the skin (subcutaneously), and LY4395089 will be given as well. You'll have various tests and check-ups at these visits to monitor your health, how the treatment is affecting you, and if your Crohn's disease symptoms are improving. This will likely involve blood tests, physical exams, and discussions about your symptoms. The research team will explain the exact schedule of visits and what each visit will involve in detail.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment or a new combination of treatments for your Crohn's disease that could improve your symptoms more than your current treatment. You would also be closely monitored by a healthcare team throughout the study. However, there are potential risks, including side effects from the medications, which will be fully explained to you. It's also possible that the treatments may not work for you, or your condition could get worse. It's very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

Mayo Clinic in Arizona - Scottsdale
Verified postcode
Scottsdale, United States· Not yet recruiting
Biopharma Informatic, LLC
Verified postcode
Los Angeles, United States· Not yet recruiting
Om Research LLC
Verified postcode
Oxnard, United States· Not yet recruiting
South Denver Gastroenterology
Verified postcode
Englewood, United States· Not yet recruiting
Gastro Health Research - Miami
Verified postcode
Miami, United States· Not yet recruiting
Ezy Medical Research
Verified postcode
Miami Lakes, United States· Recruiting
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Verified postcode
Atlanta, United States· Recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Not yet recruiting
Cotton O'Neil Digestive Health Center
Verified postcode
Topeka, United States· Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Verified postcode
Wyoming, United States· Not yet recruiting
KAD Clinical Research
Verified postcode
St Louis, United States· Not yet recruiting
Vector Clinical Trials
Verified postcode
Las Vegas, United States· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a condition that causes swelling and irritation in your digestive system, which can lead to symptoms like tummy pain and sickness.

What are the treatments being tested?

We are testing two medications: LY4395089, which is a new drug, and mirikizumab, which is another treatment already being studied. We want to see if they work better together.

How will I receive the medication?

Mirikizumab will be given either through a drip into your arm or as an injection under your skin. LY4395089 will also be given.

How long will the study last?

The study will last for about 62 weeks, which is roughly 1 year and 2 months.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.

How to find out more

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or

clinical_inquiry_hub@lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.